Suspected or confirmed Gram negative infections
Conditions
Brief summary
Individual PK parameters derived with updated popPK models: Area under the concentrationtime curve (AUC), maximum plasma concentration (Cmax), time to maximum plasma concentration (Tmax), drug clearance (CL), half-life (t1/2), minimum plasma concentration (Cmin), and steady-state volume of distribution (Vss).
Detailed description
Adverse Events (AEs), serious AEs (SAEs), and AE of special interest (AESI), as well as changes in clinical laboratory values, and vital signs following VaboremⓇ administration versus baseline.
Interventions
Sponsors
Menarini Ricerche S.p.A.
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events (AEs), serious AEs (SAEs), and AE of special interest (AESI), as well as changes in clinical laboratory values, and vital signs following VaboremⓇ administration versus baseline. | — |
Primary
| Measure | Time frame |
|---|---|
| Individual PK parameters derived with updated popPK models: Area under the concentrationtime curve (AUC), maximum plasma concentration (Cmax), time to maximum plasma concentration (Tmax), drug clearance (CL), half-life (t1/2), minimum plasma concentration (Cmin), and steady-state volume of distribution (Vss). | — |
Countries
Czechia, France, Italy, Poland, Spain
Outcome results
None listed